title: Addressing US and European device testing requirements.
abstract: Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.
authors.affiliation: Donawa Consulting, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000592:standards*; D019544:Equipment Failure Analysis / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States